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The registration of medical device products will be "untying" with the production license.

The registration of medical device products will be "untying" with the production license.

作者:taziadmin    来源:未知    发布时间:2018-11-07 14:27    浏览量:
(All-Media Reporter/Wang Jiaxin Correspondent/Shi Yaoxian) The author learned from the Provincial Food and Drug Administration that the State Drug Administration approved the "Guangdong Provincial Medical Device Registrar System Pilot Work Program" (hereinafter referred to as the "Program"). In the future, the applicants for registration of medical devices in Guangzhou, Shenzhen and Zhuhai can entrust Guangdong Province's medical device manufacturers with the production of products, allow medical device research institutions and researchers to apply for medical device market license, and explore the "unbundling" of medical device product registration and production license. Breakthroughs have been made in separate management models.

In the sales link, the Plan proposes that the registrant may sell medical devices by himself, without the need for a license or a record, or entrust a medical device business enterprise with appropriate conditions to sell medical devices. Where medical devices are commissioned for sale, the registrant shall be responsible for the quality of the medical devices commissioned for sale, sign a commission agreement with the entrusted business enterprise, clarify the rights, obligations and responsibilities of both parties, and strengthen the management of the entrusted business activities to ensure that they are sold in accordance with legal requirements.

For the existing medical device manufacturers that have registered certificates, registration and production can be "stripped". According to the Plan, the medical device manufacturers that have obtained the registration certificate of medical devices in the province may implement it with reference to the relevant provisions of the Plan.

In addition, encourage group companies to become registrants. The medical device manufacturing enterprise group company can centralize the medical device registration certificate of each holding subsidiary company to the group company. The group company allocates and integrates the products according to the production and processing capacity of each holding subsidiary company, making each subsidiary company a characteristic, advantageous and large-scale production base. The group company implements a unified quality management system for each subsidiary company, and the group company is fully responsible for the quality of all listed products.

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